Treatment of Obesity and Binge Eating: Behavioral Weight Loss Versus Stepped Care
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| ClinicalTrials.gov Identifier: NCT00829283 |
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Recruitment Status :
Completed
First Posted : January 27, 2009
Results First Posted : February 1, 2016
Last Update Posted : April 3, 2020
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Sponsor:
Yale University
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Yale University
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Brief Summary:
This controlled study will test the effectiveness of a stepped-care approach to a standard behavioral weight loss treatment for obese patients with Binge Eating Disorder (BED). The major question is whether the stepped-care approach, which begins with behavioral weight loss and then follows a decision tree for additional interventions based on early treatment response is superior to standard behavioral treatment.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Obesity Binge Eating | Behavioral: Behavioral Weight Loss Behavioral: Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy Drug: Placebo Drug: Sibutramine/Orlistat | Not Applicable |
The stepped-care arm of this study included an obesity medication intervention. At the start of the study, the active medication was sibutramine and was compared to a placebo control. On 10/8/2010, Abbott Laboratories withdrew their obesity drug sibutramine (Meridia) from the market in light of clinical trial data pointing to an increased risk for stroke and myocardial infarction. In response to this event, the investigators submitted an IRB amendment to change the active obesity medication from sibutramine to Orlistat. The IRB amendment was approved on 11/4/2010. The PI received approval from NIH/NIDDK Program Officer Robert Kuczmarski to enact this change.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 191 participants |
| Allocation: | Randomized |
| Intervention Model: | Factorial Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Treatment of Obesity and Binge Eating: Behavioral Weight Loss Versus Stepped Care |
| Study Start Date : | November 2008 |
| Actual Primary Completion Date : | November 2013 |
| Actual Study Completion Date : | November 2013 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 1
Standard Care
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Behavioral: Behavioral Weight Loss
weekly individual sessions for 6 months |
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Experimental: 2
Stepped-care
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Behavioral: Behavioral Weight Loss
weekly individual sessions for 6 months Behavioral: Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months Drug: Placebo One pill daily Drug: Sibutramine/Orlistat Sibutramine 15 mg daily or Orlistat 120mg TID |
Primary Outcome Measures :
- Number of Subjects Who Reached Binge Eating Remission [ Time Frame: 12 months follow-up ]Binge Remission (abstinence from binge eating)
Secondary Outcome Measures :
- BMI [ Time Frame: 12 months follow-up post-treatment ]The body mass index is a value derived from the mass and height of an individual. The BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m^2.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion criteria:
- Obese (BMI>=30)
Exclusion criteria:
- Medication regimen that represents medical contraindication to sibutramine
- Serious unstable or uncontrolled medical conditions that represent contraindication to sibutramine
- Pregnancy
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00829283
Locations
| United States, Connecticut | |
| Yale School of Medicine | |
| New Haven, Connecticut, United States, 06520 | |
Sponsors and Collaborators
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
| Principal Investigator: | Carlos M Grilo, PhD | Yale University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00829283 |
| Other Study ID Numbers: |
0610001922 R01DK049587 ( U.S. NIH Grant/Contract ) |
| First Posted: | January 27, 2009 Key Record Dates |
| Results First Posted: | February 1, 2016 |
| Last Update Posted: | April 3, 2020 |
| Last Verified: | April 2020 |
Keywords provided by Yale University:
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Experimental Comparator |
Additional relevant MeSH terms:
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Obesity Weight Loss Bulimia Binge-Eating Disorder Overnutrition Nutrition Disorders Overweight Body Weight Body Weight Changes Feeding and Eating Disorders Mental Disorders |
Hyperphagia Signs and Symptoms, Digestive Orlistat Sibutramine Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Obesity Agents Lipid Regulating Agents Antidepressive Agents Psychotropic Drugs Appetite Depressants |